Kornimate/medical-research-clean huggingface dataset:
stratification of the acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: the american-european consensus conference (aecc) and the berlin definitions of the acute respiratory distress syndrome (ards) could be adequate for epidemiologic studies, but it is not adequate for inclusion of patients into therapeutic clinical trials. despite recent reports on the effects of standardized ventilator settings on pao2/fio2 and fulfillment of aecc and berlin definitions of ards, it is still a matter of debate whether the assessment of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients with ards. the investigators will perform an observational, multicenter, prospective audit in a network of intensive care units in spain and china for validating and confirming that the assessment of hypoxemia at 24 hours after ards onset is the most valuable tool for stratifying and predicting outcome in patients with ards.

in 1994, the american-european consensus conference (aecc) defined ards as follows: 1) acute and sudden onset of severe respiratory distress, 2) bilateral infiltrates on frontal chest radiograph, 3) absence of left atrial hypertension or no clinical signs of left heart failure, and 4) severe hypoxemia, as pao2/fio2 ratio \ 100-≤200), and mild (\>200-≤300) on peep≥5 cmh2o. however, despite that there is sufficient evidence about the interactions between peep and fio2, the berlin criteria did not mandate the assessment of hypoxemia at 24 hours under standarized guidelines. the pao2/fio2 can be easily manipulated. alterations in peep and fio2 can dramatically change the pao2/fio2. despite recent reports on the effects of standardized ventilator settings on pao2/fio2 and fulfillment of aecc definitions of ards, it is still a matter of debate whether the assessment of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients with ards. the investigators will examine whether the assessment of hypoxemia at 24 h after ards diagnosis under standard guidelines for ventilatory management have an impact on the stratification of lung severity and on predicting mortality of ards patients in the intensive care unit.

Eligibility criteria:
inclusion criteria: * patients meeting the aecc definition for ards on peep greater or equal than 5 cmh2o (or the berlin criteria for moderate and severe ards). exclusion criteria: * none

Keywords: mechanical ventilation, stratificacion, lung severity
efficacy and safety of industrially prepared 3 chamber bag parenteral nutrition for premature infant

Conditions: Weight Gain; Intravenous Nutrition Adverse Reaction; Premature

Summary: this study was designed to evaluate whether industrially prepared standardizing total parenteral nutrition is at least non-inferior to compounded tpn and provides nutritional intakes according to the new guidelines and provides the expected weight gain in preterm babies with a birth weight between 1250 and 2000g admitted in our nicu between 2015 \& 2018

parenteral nutrition (pn) is mandatory in the nursing of very low birth weight ((v)lbw)) babies during the first weeks of life. numerous discussions exist about the indication of individually tailored or standardized pn formula. (v)lbw babies are known as fragile unstable babies with special requirements. many neonatal intensive care units (nicu) prefer a tailored prescription for that kind of patients. making a daily individual tailored prescription is often complex for numerous reasons: it is time consuming, it may be source of faults and incompatibility, it needs a senior neonatologist to review the prescription and has to arrive during daytime hours at the pharmacy. tailored pn is often administrated with a delay, as one can only prescribe having reviewed the results of blood sampling. this delay can range from 6 to 12 hours. numeta g13°/0e is a standardized, industrial, ready to use pn specifically designed to meet the nutritional requirements of preterm newborn infants for whom enteral nutrition is not possible or insufficient. new espghan guidelines were published in 2018 recommending nutritional intake targets of 2.5g-3.5 amino acids per kg/day and 90-120 kcal/kg/day. our nicu wants to evaluate their compliance to these new guidelines. before november 2016, it was common practice in chu tivoli to feed the preterm baby with a compounded binary tpn solution and lipids were administered separately in y-line. in november 2016, we switched to an all-in-one tpn with standardized composition (numeta g13%e, baxter) numeta g13°/0e is stored at room temperature and is ready to be infused in a few minutes. numeta g13%e is presented in the form of a three-chamber bag (3cb) or a two chamber bag (2cb). the activation of the lipid bag is optional, resulting in a solution containing glucose, electrolytes, amino acids and (optionally) lipids. additions of water, electrolytes in the bag or on the side help to customize the bag to the specific needs of newborns that need intensive care.

Eligibility criteria:
inclusion criteria: * premature patients in the nicus with a birth weight between 1250 and 2000g exclusion criteria: * death or parenteral duration less than 10 days
ondansetron for the treatment of heavy drinking among emerging adults

Conditions: Alcohol Abuse; Alcoholism

Summary: this study will evaluate the efficacy of ondansetron + basics plus in reducing severe or binge drinking among emerging adults. basic plus (brief alcohol screening and intervention for college students) has been the most validated brief intervention among college students. the basics program provides personal feedback, motivation, and strategies that enhance normative drinking patterns

we propose to conduct a 9 week study to test the efficacy of ondansetron in a heavy drinking (non-dependent) emerging adult population. we will enroll individuals between the ages of 18 and 25 years as this period overlaps with the general population of those attending college and who can be defined as emerging adults. we will conduct a double-blind control study in which 150 individuals will be randomized into 2 groups, therefore the n will be 300.

Eligibility criteria:
inclusion criteria: * white males and females who have given written informed consent. * ages 18 through 25;also, patients must weigh ≥40 kg and ≤140 kg. * good physical health as determined by a complete physical examination, an ekg within normal limits, and laboratory screening tests within acceptable parameters. * at least an average of one episode of binge or heavy drinking per week in the past month prior to enrollment. for men and women, that is ≥5 and ≥4 drinks/drinking day, respectively.they also need to report at least one day of heavy drinking within the 7 days prior to randomization. * the pregnancy test for females at intake must be negative. additionally, women of childbearing potential must be using an acceptable form of contraception. * literate in english and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments. * answer an advertisement in the newspaper/radio/television, and express a wish to stop heavy drinking. * willingness to participate in behavioral treatments to stop heavy drinking exclusion criteria: please contact site for additional information

Keywords: alcohol abuse binge drinking severe drinking alcoholism heavy drinking
ecog bmi for motor and speech control

Conditions: ALS; SCI - Spinal Cord Injury; Stroke; Multiple Sclerosis; Muscular Dystrophies

Summary: test the feasibility of using electrocorticography (ecog) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

ecog is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. with this ecog-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ecog brain signals can be used to produce speech.

Eligibility criteria:
inclusion criteria: 1. age \&gt; 21 2. limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (als), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy. 3. disability, defined by a 4 or greater score on the modified rankin scale, must be severe enough to cause loss of independence and inability to perform activities of daily living. 4. if stroke or spinal cord injury, at least 1 year has passed since onset of symptoms 5. must live within a two-hour drive of ucsf exclusion criteria: 1. pregnancy or breastfeeding 2. inability to understand and/or read english 3. inability to give consent 4. dementia, based on history, physical exam, and mmse 5. active depression (bdi \&gt; 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (ocd), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.) 6. history of suicide attempt or suicidal ideation 7. history of substance abuse 8. co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure 9. inability to comply with study follow-up visits 10. any prior intracranial surgery 11. history of seizures 12. immunocompromised 13. has an active infection 14. has a csf drainage system or an active csf leak 15. requires diathermy, electroconvulsive therapy (ect), or transcranial magnetic stimulation (tms) to treat a chronic condition 16. has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies 17. allergies or known hypersensitivity to materials in the blackrock neuroport array (i.e. silicone, titanium) or the pmt subdural cortical electrode (silicone, platinum iridium, nichrome)
long-term therapy outcomes when treating chronic kidney disease (ckd) patients with paricalcitol in german and austrian clinical practice

Conditions: Kidney Insufficiency; Secondary Hyperparathyroidism

Summary: the purpose of this study is to obtain data on the safety and effectiveness of zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. a period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

according to protocol amendment of 16 october 2010 austria is participating in this study. paricalcitol injection (intravenous (iv) therapy) was approved in germany in december 2004 and in austria in june 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. in april 2008 in germany and in january 2008 in austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with chronic kidney disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis. postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare. accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. in this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. a period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Eligibility criteria:
inclusion criteria: * the inclusion criteria are based on the summary of product characteristics for paricalcitol injection and capsules: prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease * patients not treated with paricalcitol for at least 6 months prior to inclusion in this study exclusion criteria: * the contraindications listed in the summary of product characteristics for paricalcitol injection and capsules apply * an additional exclusion criterion is a parathyroid hormone- value of \> 1000 pg/ml (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol

Keywords: observational study paricalcitol treatment of hyperparathyroidism chronic kidney disease stage 3, 4 and 5 (ckd stage 3, 4 and 5) chronic kidney disease zemplar shpt secondary
v501 immunogenicity study in females age 9 to 17 years (v501-028)

Conditions: HPV Infections

Summary: the study evaluates the immunogenicity, safety and tolerability of v501 in preadolescent females


Eligibility criteria:
inclusion criteria: * virginal female subject aged 9 to 17 years exclusion criteria: * male subject
study of sotorasib, panitumumab and folfiri versus folfiri with or without bevacizumab-awwb in treatment-naïve participants with metastatic colorectal cancer with kras p.g12c mutation

Conditions: Metastatic Colorectal Cancer

Summary: the aim of this study is to compare progression free survival (pfs) in treatment-naïve participants with kras p.g12c mutated metastatic colorectal cancer (mcrc) receiving sotorasib, panitumumab and folfiri vs folfiri with or without bevacizumab-awwb.


Eligibility criteria:
inclusion criteria: * pathologically documented metastatic colorectal adenocarcinoma with kras p.g12c mutation by a locally validated assay. * central confirmation of kras p.g12c mutation * measurable metastatic disease per recist v1.1 criteria. * eastern cooperative oncology group (ecog) performance status of ≤ 1. * adequate organ function. exclusion criteria: * active, untreated brain metastases. * leptomeningeal disease * previous treatment with a kras p.g12c inhibitor * history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline ct scan

Keywords: sotorasib panitumumab folfiri bevacizumab-awwb oncology
role of nutritional support in idiopathic male infertility

Conditions: Infertility, Male

Summary: approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a test dietary supplement (tds), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). before intake, and 2 and 4 months after the commencement of tds, all males will have spermogram. after 6-month use of the tds and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn


Eligibility criteria:
inclusion criteria: 1. informed consent form signed; 2. age: 21-50; 3. idiopathic male infertility; 4. idiopathic oligo- and/or astheno- and/or teratozoospermia; 5. stated availability throughout the study period and a mobile phone exclusion criteria: 1. allergy to any component of the dietary supplement; 2. known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility; 3. known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility; 4. inflammatory bowel disease; 5. known moderate to severe disease of any systems; 6. known or suspected sexually transmitted diseases; 7. alcohol or drug addiction of any couple counterpart as suspected by investigator; 8. difficulty to comprehend study requirements as judged by investigator; 9. use of any investigational product within the previous 3 months before entering the study; 10. use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal ct-p10 therapeutic equivalence trial

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal ct-p10 therapeutic equivalence trial.


Eligibility criteria:
inclusion criteria: 1. patient has histologically proven dlbcl, which may represent de novo dlbcl or dlbcl arising from transformed follicular lymphoma or chronic lymphocytic leukemia. 2. patient has relapsed or refractory cd20-positive disease following previous first-line systemic chemotherapy. patients who have failed to achieve complete remission with previous chemotherapy are defined as refractory, and those who relapsed after an initial complete remission are classified as having relapsed. a biopsy must be performed to confirm diagnosis of relapsed disease. tumor tissue within 6 months of day 1 of cycle 1 of study treatment will be used for the central review. 3. patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension, or 1.1 to 1.5 cm in the longest dimension, and greater than 1.0 cm in the shortest axis) that has not previously been irradiated or has grown since previous irradiation exclusion criteria: 1. patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. 2. patient has had prior allogeneic or asct. 3. patient has received any other anticancer therapy within 28 days before day 1 of cycle 1 of study treatment and more than 1 prior line of chemotherapy, with the exception of having received the last dose of rituximab within 6 months before day 1 of cycle 1 of study treatment if they have undergone prior treatment with rituximab.

Keywords: dlbcl, biosimilar
time-specific exercise in circadian context

Conditions: Osteopenia; Osteoporosis; Aging

Summary: the project aims to explore the mechanisms, by which physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity.

the main aim of the project is to examine the effect of as well as of the three-month, timely specific training intervention on the functionality of circadian organization in elderly volunteers. the additive aim is to examine the effect of lifelong endurance physical activity, along with the experimental training intervention on the body composition, bone density, and selected hormonal, biochemical, histological and molecular indicators of metabolic health. partial aims are as follows:n to explore the effect of morning and afternoon training on the most significant parameters, identified by the previous cross-sectional study, in sedentary elderly. furthermore, to clarify adaptation mechanisms of experimental training protocol on selected parameters, that may explain possible differences in mechanisms of active and passive aging.

Eligibility criteria:
inclusion criteria: * no history of regular physical activity training and exercise of more than 150 minutes of moderate or 75 minutes of higher intensity per week. * body mass index (bmi) between 18.5 and 30 kg/m2 for all groups exclusion criteria for probands will be: * recent or current infection, physical disability, * malignant, cardiovascular, metabolic, autoimmune diseases, * malnutrition and pharmacological interference (e.g., steroids, non-steroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs). use of performance enhancing drugs in the past and during the study period will condition exclusion. exclusion criteria: * recent or current infection, physical disabilities, * malignant, cardiovascular, metabolic, autoimmune diseases, * malnutrition and pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs). use of performance-enhancing drugs in the past and during the study period will condition exclusion.

Keywords: bone mineral density circadian rhythm elderly
screening of biomarkers on endometrial cancers

Conditions: Endometrial Cancers

Summary: ovarian cancer is the first mortality rate of gynecologic malignancies. the incidence of ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies in the women in taiwan. from the above-mentioned data, ovarian cancer indeed is a disease that should be respected, however, there were only few of research work focusing on it in taiwan. despite the widespread use of aggressive cytoreductive surgery and the introduction of chemotherapy regimens, the overall survival has changed little over the last two decades. the basic problem in treating epithelial ovarian cancer is that once it has spread beyond the ovary, it is exceedingly difficult to control and ultimately to cure. more than 70% of ovarian cancer patients were advanced stage when diagnosed. to study the mechanisms of carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this disease and develop new treatment strategies for ovarian cancer in the future. we have established an ascitogenic itnraperitoneal tumor cell line-wf3 in the mouse model in our previous two-year project of nsc grant (grant number (nsc90-2314-b-002-457 and nsc91-2341-b-002-315). our group found that, mesothelin, this molecule is highly related with the carcinogenesis, tumor progression and tumor metastasis in our animal model and human cancer tissues. to further evaluate the role of mesothelin in ovarian cancer and elucidate the potential of mesothelin as a target antigen for immunotherapy,


Eligibility criteria:
inclusion criteria: * patients with endometrial cancers who undergo hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital. all of the patients received four to six courses of adjuvant platinum-containing chemotherapy.histologic grading was according to international union against cancer criteria (28). the stage of disease was classified according to the international federation of gynecology and obstetrics (figo, 1987). pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. the histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. the maximal diameter of the residual tumor after surgery will be also recorded. all patients will be followed up at 3-month intervals.